1,3-dioxane, 2-(3,3-dimethyl-1-cyclohexen-1-yl)-2,5,5-trimethyl

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

23/07/2015-31/07/2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report Date:

2015

Materials and methods

Test guideline

Qualifier:

according to

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. certificate)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Specific details on test material used for the study:

Received on 007/15 from the sponsor. It presented as a colourless translucent liquid.
Batch number: 100026324
97.5% for isomer 1 of Maderal

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

yes

Remarks:

acetone

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Source: Phytosafe s.a.r.l., 2 rue Mar Dormoy, 64000 PAU, France
Age : Less than 24h at test initiation
Fed with living celles of green algaes
Adult females were transferred in a new volume before the test initiation. Young daphnids produced within 24h were used for the tests.
Daphnids not fed during the exposure period.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Test temperature:

20.4°C and kepr constant at +/- 1°C for both range-finding and definitive test

pH:

Water control : between 7.9-7.7
Solvent control : between 7.7
Maderal : between 7.9-7.6 in all tests

Dissolved oxygen:

Water control : between 8.4-7.8 mg/L
Solvent control : between 8.4-7.7 mg/L
Maderal : between 8.4-7.6 mg/L in all tests

Nominal and measured concentrations:

Nominal concentrations:
Range finding test: 0.002 ; 0.02 ; 0.2 ; 2.1 ; 20.6 mg/L
Definitive test: 0.6 ; 1.2 ; 2.5 ; 5.1 ; 10.3 mg/L

Details on test conditions:

Test medium: M4 medium freshly reconstituted from mineral stock solutions.
Use of a Water control and a solvent control (actetone)
Tubes maintained in the dark in a climatic chamber

Reference substance (positive control):

yes

Remarks:

Potassium dichromate, CAS n°7778-50-9, AnalaR Prolabo Ref. 26784.231, batch 07J050002

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

ca. 1.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

ca. 1.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

ca. 2.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

ca. 2.2 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

EC50-24h value is between 0.6-2.1 mg/L. Calculations gave 1.33 mg/L as the measured value.
The results fulfilled the validity criteria base on Phytosafe historical data.

Reported statistics and error estimates:

Effect pf Maderal, 95% confidence intervals
T0+24h : 1.0-6.7 mg/L
T0+48h : 1.0-4.5 mg/L

Effect of Potassium dichromate (95% confidence intervals)
T0+24h : 0.93-1.90 mg/L

Any other information on results incl. tables

Analytical verification: test item concentrations were maintained within 80 -120% of the nominal values over the test period.

Percentage of immobilization:

Water/Solvent control: 0% in every replicates

Other observations:

Initial / final pH similar between the treatment test and both control test

Final oxygen > 3mg/L in every cases

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Executive summary:

The Short-term toxicity to aquatic invertebrates test was performed according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test).

The results are the following:

NOEC=1.2mg/L

EC50=2.2mg/L